MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description

It was reported that the patient had their generator and lead explanted due to an infected collection of fluid around the battery.The patient had been on antibiotics continuously since implant in (b)(6) 2017.Prior to explant, the patient had two neck wound revisions due to would dehiscence.During the second case of wound dehiscence, the patient's electrode coil was "trying to escape." review of the manufacturer's device history records verified sterilization of the lead and generator prior to release.Device evaluation is not necessary as infection and wound dehiscence is not related to the functionality or delivery of therapy of the device.No further relevant information has been received to date.

Event Description

It was reported by the nurse that they could not identify any reason/s for why there were significant complications with this child and his device for either infections or wound dehiscence.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7723003
• MDR Text Key: 115120515
• Report Number: 1644487-2018-01293
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750016
• UDI-Public: 05425025750016
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2019
• Device Model Number: 102
• Device Lot Number: 204122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR